Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

All patients treated for breast cancer with curative intent in MAASTRO clinic in 2002-2003 who are still alive, who respond to our invitation letter and are willing to participate to visit the outpatient clinic. These patients will be sent a questionnaire with both basic and more detailed questions on their disease-status and on quality of life related outcome. In addition they will be asked to come to MAASTRO clinic for a more detailed evaluation of late side effects of the treatment. Patients are seen by a physician or a physician assistant at the outpatient clinic.

The participants are seen at the outpatient clinic by a physician or a physician assistant. To analyse fibrosis clinical examination of the breast will be performed. To analyse shoulder function anteversion / retroversion, abduction / adduction and internal / external rotation will be measured. To analyse edema the arm circumference will be measured 15 cm above and below the medial epicondyle (both sides). Also, a photograph of the breast will be made for cosmetic analysis using standardized procedures. Finally a blood sample or saliva will be obtained, if the patient has given written informed consent to participate in the Biobank.

Outpatient clinic

Liesbeth J Boersma, M.D., Ph.D.

In order to evaluate the late outcome in patients curatively treated for breast cancer, a special outpatient clinic will be developed.

There are two main purposes of the outpatient clinic. The first purpose is evaluating the results of the radiation treatment by mapping A) late toxicity and B) tumour control and survival.

The second purpose is that this outpatient clinic for late outcome will also function as a pilot for a new CAT (Computer Assisted Theragnostics, abbreviated CAT project) in which multiple late outcome variables will be recorded. In this pilot we want to investigate whether physical presence of the patient on the outpatient clinic, allowing physical examination, has any added value to the questionnaires filled in by the patient at home.

The ultimate aim of this new CAT project is to use these multicentric data to develop models for predicting both oncological outcome and late side effects. Insight in the beneficial and adverse effects of a certain treatment using these predictive models, will be required choose the optimal treatment for the individual patient using a shared decision making process.

As part of the study a blood sample or saliva will be obtained, if the patient has given written informed consent to participate in the Biobank. The purpose to determine, by means of DNA and protein analysis, the relationship between DNA and protein profiles and a number of endpoints, which are important for the patient such as overall survival and side effects.

For detailed information: ClinicalTrials.gov Identifier: NCT01084785

Outpatient Clinic for Late Outcome for Breast Carcinoma in MAASTRO Clinic.

Outpatient Clinic to Evaluate Late Outcome in Patients Curatively Treated for Breast Carcinoma in MAASTRO Clinic.

The following the potential risk factors are recorded:

1. Patient related risk factors:

   * Age at time of diagnosis
   * Genetic and protein profile blood samples (optional with informed consent of participant)
   * Smoking
2. Treatment related factors:

   * Type of surgery
   * Excision volume
   * Post-operative complications
   * Resection margins Free
   * Scar visibility
   * Axillary surgery
   * Radiotherapy
   * Fractionation scheme
   * Target volumes
   * Dose-volume parameters
   * Actually delivered dose
   * Chemotherapy
   * Hormonal treatment
   * Immunotherapy
3. Tumor related factors

   * Localization
   * Stage
   * Differentiation grade
   * Hormonal receptors
   * HER-2
   * Genetic profile

As primary endpoint, for each patients the STAT score will be determined, summarizing locoregional late toxicity, e.g. fibrosis, cosmetic outcome, shoulder dysfunction, lymphedema arm, pain \[Barnett et al, 2012\].

The secondary endpoint is 10 year survival rate, and late toxicity, other than locoregional late toxicity, e.g. fatigue, neuropathy, menopausal symptoms, cardiac and pulmonary symptoms, and secondary tumors. Survival will be divided in overall survival, locoregional recurrence free survival and distant metastases free survival. For each patient other toxicity at 10 year will be scored according to CTC-AE 4.

Maastricht Radiation Oncology

Behaviors and Mental Disorders

Symptoms and General Pathology

Nervous System Diseases

Anxiety Disorders

Pain

Pain, Procedural

Mental Disorders

Psychotic Disorders

Neurologic Manifestations

Virtual Reality was used before and during punctures. For every observation patients underwent either port puncture or peripheral venous puncture. One examination was carried out according to the Standard-of-Care. The other one was carried out with the additional use of VR. Participants watched a passive distraction video.

Virtual Reality

Urs Mücke, Dr.

Pain and anxiety-inducing interventions have a major impact on pediatric patients. Pain reduction by virtual reality (VR) during port and vein punctures is well studied. This study investigates peri-interventional reduction of pain, anxiety and distress using VR compared to the standard of care (SOC) in a pediatric oncology outpatient clinic.

In a randomized, controlled cross-over design, patients aged 6-18 years experience potentially painful interventions accompanied by VR. All patients included in the study underwent port puncture or peripheral venous puncture in two observations : SOC (A) and VR (B) in a randomized order. Observational instruments include Numeral Rating Scale (NRS), Faces Pain Scale revised (FPS-r), Behavioral Approach Avoidance Distress Scale (BAADS), modified Yale Preoperative Anxiety Scale (mYPAS-SF). In addition, parents and staff are interviewed. Specific conditions for VR in an outpatient clinic setting are being discussed.

Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic

Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic: a Randomized Controlled Trial

Parents and patients were given different statements

Involved staff were asked about experience/feedback

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Outpatient Clinic for Late Outcome for Breast Carcinoma in MAASTRO Clinic.	NCT01978756	Breast Cancer	Outpatient clin...	18 Years -	Maastricht Radiation Oncology
Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic	NCT06235723	Pediatric Cance... Procedural Anxi... Procedural Pain	Virtual Reality	6 Years - 18 Years	Hannover Medical School

Spots Global Cancer Trial Database for outpatient clinic